A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy Volunteers (NCT05993806) | Clinical Trial Compass
CompletedPhase 1
A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy Volunteers
South Korea50 participantsStarted 2023-06-02
Plain-language summary
This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD3 in healthy volunteers.
Who can participate
Age range19 Years – 64 Years
SexALL
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Inclusion Criteria:
* A subject aged 19 to less than 65 years at the time of the screening visit
* A subject with a body weight of 55kg or higher and a body mass index (BMI) of 18.0 kg/m2 to 29.9 kg/m2, inclusive
* A subject considered appropriate to participate in the study according to the results of lab tests such as the hematological test, blood chemistry test, serum test, urinalysis, etc. and ECG set and conducted by the principal investigator (or a delegated study physician) according to the characteristics of the investigational product
* A subject who agreed to exclude the possibility of pregnancy by having themselves, their spouses, or partners use medically appropriate contraceptive methods and not to provide sperm or egg from the first dose to 7 days after the last dose of IP administration
* A subject who voluntarily signed the informed consent form after listening to and understanding sufficient explanation on the purpose, content of this clinical study, the characteristics of the investigational product, expected adverse events, etc.
Exclusion Criteria:
* A subject who has clinically significant diseases in the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otolaryngeal system, skin system, and ophthalmic system or has had the diseases
* A subject who had gastrointestinal surgery (excluding sim…